Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MRN — Predicate Candidate Screening
33 FDA 510(k) clearances under this product code; the 50 most recent screened below.
120 daysmedian FDA review time
436 days90th percentile
33clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242374 | ULSPIRA TS™ Nitric Oxide Therapy System | Airgas Therapeutics, LLC | 2025-01-17 | 161 | 0 |
| K242578 | EVOLVE Nitric Oxide Delivery System | Mallinckrodt Manufacturing, LLC | 2025-01-03 | 127 | 0 |
| K240410 | EVOLVE Nitric Oxide Delivery System | Malinckrodt Manufacturing, LLC | 2024-05-28 | 106 | 0 |
| K233251 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2024-05-23 | 238 | 2 |
| K222930 | Evolve Nitric Oxide Delivery System | Mallinckrodt Manufacturing, LLC | 2023-12-06 | 436 | 0 |
| K231823 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2023-08-11 | 51 | 2 |
| K212409 | Ulspira TS Nitric Oxide Therapy System | Airgas Therapeutics | 2023-06-30 | 696 | 0 |
| K211153 | Inomax DSIR | Mallinckrodt Manufacturing, LLC | 2023-04-20 | 731 | 0 |
| K220898 | NOxBOXi Nitric Oxide Delivery System | Linde Gas & Equipment, Inc. | 2022-04-27 | 30 | 2 |
| K201339 | The NOxBOXi Nitric Oxide Delivery System | Praxair, Inc. | 2020-06-19 | 30 | 2 |
| K200389 | INOmax DSIR Plus | Mallinckrodt Manufacturing, LLC | 2020-06-17 | 120 | 0 |
| K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | International Biomedical | 2020-03-10 | 84 | 0 |
| K171696 | NOxBOXi Nitric Oxide Delivery System | Praxair Distribution, Inc. | 2018-10-02 | 482 | 4 |
| K143213 | INOmax DSIR Plus MRI | Ino Therapeutics/Ikaria | 2015-07-10 | 242 | 0 |
| K131686 | INOMAX DSIR (DELIVERY SYSTEM) | Ino Therapeutics/Ikaria | 2013-11-29 | 172 | 2 |
| K130605 | INOMAX DSIR (DELIVERY SYSTEM) | Ino Therapeutics | 2013-05-02 | 56 | 0 |
| K121021 | INOMAX DS (DELIVERY SYSTEM) | Ino Therapeutics | 2012-09-24 | 173 | 0 |
| K120216 | GENOSYL MV-1000 | Geno, LLC | 2012-05-16 | 113 | 0 |
| K113272 | INOMAX DS(DELIVERY SYSTEMS | Ino Therapeutics, LLC/Dba Ikaria | 2012-02-29 | 117 | 0 |
| K110344 | INOMAX DSIR (DELIVERY SYSTEM) | Ino Therapeutics | 2011-06-24 | 140 | 0 |
| K110635 | INOMAX DS(IR) (DELIVERY SYSTEM) | Ino Therapeutics, LLC/Dba Ikaria | 2011-06-23 | 111 | 0 |
| K093922 | INOMAX DS | Ino Therapeutics | 2010-04-15 | 114 | 1 |
| K092545 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Ino Therapeutics, LLC | 2010-03-10 | 203 | 0 |
| K093260 | AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM | International Biomedical, Ltd. | 2009-12-16 | 58 | 0 |
| K081691 | INOMAX DS (DELIVERY SYSTEM) | Ino Therapeutics, LLC | 2008-08-28 | 72 | 0 |
| K080484 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Ino Therapeutics | 2008-08-06 | 166 | 0 |
| K071516 | INOMAX DS | Ino Therapeutics, LLC | 2007-10-03 | 121 | 0 |
| K070867 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Ino Therapeutics, LLC | 2007-04-27 | 29 | 0 |
| K061901 | INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Ino Therapeutics | 2006-12-14 | 162 | 3 |
| K033779 | VIANOX DELIVERY SYSTEM, MODEL II | Pulmonox Medical, Inc. | 2004-01-26 | 53 | 0 |
| K000653 | AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL | Pulmonox Medical Corp. | 2000-08-04 | 158 | 0 |
| K000186 | DATEX-OHMEDA INOVENT DELIVERY SYSTEM | Datex-Ohmeda | 2000-02-10 | 27 | 1 |
| DEN000001 | OHMEDA INOVENT DELIVERY SYSTEM | Ohmeda Medical | 2000-01-11 | 4 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda